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Postoperative Quality of Recovery After Combined Lumbar Plexus-Sciatic Nerve Block (LPB-SNB)

Postoperative Quality of Recovery After Combined Lumbar Plexus-Sciatic Nerve Block for Lower Extremity Orthopaedic Surgeries: A Double-Blind Randomised Controlled Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06301503
Enrollment
100
Registered
2024-03-08
Start date
2024-03-09
Completion date
2024-05-02
Last updated
2024-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Extremity Surgery

Brief summary

The goal of this clinical trial is to evaluate the efficacy of lumbar plexus-sciatic nerve block (LPB-SNB) by comparing the postoperative quality of recovery as assessed by the Quality of Recovery-40 (QoR-40) questionnaire, in patients who received a combination of LPB-SNB versus patients who received the traditional intravenous opioid, after lower extremity orthopaedic surgeries with spinal anaesthesia. The main questions it aims to answer are: * Will there be a significant difference in QoR-40 scores between both groups? * Will the combined LPB-SNB significantly reduces opioid consumption within the first 24 hours? * Will the combined LPB-SNB significantly increases postoperative duration of analgesia? Participants will: * Receive a coded sealed opaque envelope containing their randomly allocated intervention group; first group receives a combination of lumbar plexus-sciatic nerve block, while the second group receives no block at all. This information would not be disclosed to the participants. * Receive an explanation on how to use the patient controlled analgesia (PCA) to deliver intravenous opioid, and instructions on filling in the QoR-40 questionnaire. Researchers will then compare the results between both groups to see if the combined lumbar plexus-sciatic nerve block successfully provides adequate analgesia and enhance postoperative quality of recovery after lower extremity orthopaedic surgeries.

Detailed description

Following lower extremity orthopaedic surgeries, acute postoperative pain management plays a crucial on each patient's quality of recovery. Postoperative pain are usually classified as nociceptive, neuropathic, mixed, psychogenic, or idiopathic and so, a single treatment might be insufficient to treat it adequately. Multimodal analgesia, encompassing techniques such as the neuraxial blockade, peripheral nerve blocks, infiltration, patient-controlled opioid analgesia, and nonsteroidal anti-inflammatory drugs (NSAIDS), has been extensively investigated with aims to relieve postoperative pain. Lumbar Plexus Block (LPB) and Sciatic Nerve Block (SNB) are peripheral nerve block techniques consisting of the two large nerve branches that innervate the lower leg area. The combination of these two blocks (LPB-SNB), guided by ultrasonography (USG), blocks pain sensation throughout the lower extremity, and has been studied as an effective multimodal analgesia technique to relieve postoperative pain. This technique can minimize postoperative pain and also reduce the amount of opioid consumption, thereby reducing the incidence of postoperative nausea and vomiting (PONV). Patients' opinions of their medical care are the subject of an expanding array of assessment instruments being developed to gauge the level of postoperative recovery. The QoR-40 questionnaire is gaining popularity due to considerable validation of its utility in measuring quality of recovery. This questionnaire is appropriate for its intended use, responsive to changes in the therapeutic setting, and can yield reliable findings. The QoR-40 is a useful tool for assessing the anaesthesia and postoperative recovery quality in patients undergoing peripheral nerve blocks as well as in ordinary clinical practice. Nonetheless, there is currently limited research using the QoR-40 questionnaire to assess the quality of recovery in studies evaluating the efficacy of peripheral nerve blocks. This randomised controlled, double-blind and single-center trial will be conducted in a tertiary care hospital with aims of evaluating the efficacy of combined LPB-SNB compared to the traditional intravenous opioid in providing adequate analgesia after lower extremity orthopaedic surgeries with spinal anaesthesia with its primary outcome being the patient's postoperative quality of recovery as assessed by the QoR-40 questionnaire.

Interventions

DRUGUSG Guided Combined LPB-SNB with Isobaric Bupivacaine

Local anesthetic infiltration of 2% lidocaine (3ml) along with injection anaesthetic agent consisting of isobaric bupivacaine 0.25% (20 ml)

DRUGControl

Local anesthetic infiltration of 2% lidocaine (3ml)

Sponsors

Udayana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Numbers were prepared in sealed envelopes prepared by a third party not involved in the study to ensure allocation concealment, and handed over to the anesthetist performing the block before surgery. Both participants and outcome assessors would be blinded to the group allocation.

Intervention model description

One hundred participants are to be randomly assigned by a computer-generated random number table into two parallel groups and 1:1 allocation to either receive a combination of LPB-SNB or no block at all.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients undergoing lower extremity orthopaedic surgery with spinal anaesthesia * Patients aged between 18-65 years * Patients with American Society of Anesthesiologists (ASA) physical status classification of I-III * Patients with a body mass index (BMI) between 18-30 kg/m2

Exclusion criteria

* Patients with a history of allergy towards the local anaesthetic agents used * Patients with contraindication to regional anaesthesia based on the American Society for Regional Anesthesia guidelines * Patients with pre-existing mental or psychological disorders

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Quality of Recovery as assessed by the QoR-40 questionnaire24 hours postoperativelyThe QoR-40 questionnaire is gaining popularity due to considerable validation of its utility in measuring quality of recovery. The QoR-40 questionnaire has 40 questions divided into 5 assessment dimensions, namely comfort (12 questions), emotions (9 questions), physical independence (5 questions), support (8 questions) and pain (6 questions), where each question has a value of 1 to 5 based on the Likert scale.

Secondary

MeasureTime frameDescription
Postoperative Intravenous Opioid Consumption24 hours postoperativelyTotal opioid consumption within 24 hours after lower extremity orthopaedic surgery (in milligrams).
Postoperative Analgesia DurationWithin 24 hours postoperativelyThe duration of the postoperative analgesia, measured from the time the surgery was done (control group) or combined block was given (combined LPB-SNB group) till the time when participant first presses the PCA button in request of intravenous opioid (in minutes)

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026